Digital Pathology Resource Guide

Transcription

1 2017 VERSION 7.0 ISSUE NO. 2 Digital Pathology Resource Guide The Digital Pathology Resource Guide highlights resources that provide awareness and understanding of this technology.

2 Opinions expressed in this document are the authors own and do not necessarily reflect an endorsement by the CAP of any organization, equipment, reagents, materials, or services used by participating laboratories. None of the contents of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without the prior written permission of the publisher.

3 Goal of this Resource Guide and How to Use It What is the Resource Guide? The Digital Pathology Resource Guide is one of four CAP Resource Guides that bring a set of resources together in one place to focus on a specific hot-topic technology important to pathologists. Each comprehensive guide highlights current resources, such as a curated set of journal articles, and a collected set of CAP resources, that includes learning opportunities, proficiency testing, and accreditation that are related to this technology. Also, each Resource Guide includes an Insights from Adopters section to gain perspective from pathology leaders in the field. In sum, each Resource Guide provides a one-stop resource that will assist busy pathologists to find valuable information about a dynamic and important emerging technology. How to Use This Digital Pathology Resource Guide This Resource Guide is designed in a modular manner to facilitate its use in several different ways. For example, the guide may be used in its entirety as a comprehensive guide to the rapidly evolving field of digital pathology. Conversely, it may be used by a pathologist to focus on and gain a current understanding of the application of digital pathology to a very specific organ system or disease process. The tables are designed not only to organize and summarize the contents of a section but also to serve as stand-alone, quick reference guides to a topic. To some, these tables may hold the greatest value and become a frequently used reference. The Adopters sections will undoubtedly prove to be of great value to those contemplating or actually taking the plunge into the enhanced application of digital pathology approaches to their practice. Special Features of the Digital Pathology Resource Guide The Digital Pathology Resource Guide includes an introduction to the basic principles behind and instrumentation used for digital pathology, as well as

4 Goal of Guide regulations inside and outside the US. The curated journal articles cover whole slide imaging (WSI), workflow considerations, and clinical applications. A section suggesting how pathologists can get started in digital pathology is also included. The Resource Guide highlights a number of digital pathology-related activities that pathologists can take advantage of such as textbooks, mobile pathology apps, societies, and conferences. Editors of the Digital Pathology Resource Guide The CAP s Digital Pathology Committee has put together this resource guide to promote the use of digital tools in the practice of pathology. The authors are the members of this committee and a group of non-member advisors who are practicing users of digital pathology; each member has unique experience/expertise. Our target audience includes practicing pathologists and educators. Jason Hipp, MD, PhD (Senior Editor) Thomas W. Bauer, MD, PhD, FCAP Cleveland Clinic Foundation Marilyn M. Bui, MD, PhD, FCAP H Lee Moffitt Cancer Center Toby C. Cornish, MD, PhD, FCAP University of Colorado School of Medicine Andrew J. Evans, MD, PhD, FCAP University of Toronto Eric F. Glassy, MD, FCAP Affiliated Pathologists Medical Group Mark Lloyd, PhD, MSM Inspirata, Inc. Robert S. McGee, Jr., MD, PhD, FCAP Covance Clinical Laboratory Services Doug Murphy, MT (ASCP) College of American Pathologists Dennis G. O Neill, MD, FCAP Manchester Memorial Hospital Liron Pantanowitz, MD, FCAP UPMC Anil V. Parwani, MD, PhD, MBA, FCAP Ohio State University, Wexner Medical Center B. Alan Rampy DO, PhD, FCAP University of Texas, Dell Medical School Mohamed El-Sayed Salama, MD ARUP Laboratories Rebecca Waters, DO - University of Texas Medical Branch Kelly Westfall College of American Pathologists The authors would like to acknowledge the many contributions of Ms. Westfall to develop this Resource Guide and thank her for her steadfast dedication and patience. The CAP has four Pathology Resource Guides: Pathology Resource Guide: Precision Medicine Pathology Resource Guide: Digital Pathology Pathology Resource Guide: In Vivo Microscopy Pathology Resource Guide: Clinical Informatics

5 Table of Contents Section 1 Digital Pathology: The Basics 1.1 Background and Framework 1.2 Components of Whole Slide Imaging 1.3 Current and Emerging Applications of Digital Pathology 1.4 Why Use Digital Pathology? Page 1 Page 1 Page 2 Page 3 Page 9 Section 2 Clinical Applications of Digital Pathology: Current and Emerging 2.1 Clinical Application Overview 2.2 Frozen Section Interpretation 2.3 Primary Diagnosis 2.4 Consultation/Expert Second Opinion/ Intrapractice Consultation 2.5 International In-sourcing 2.6 Clinical Conferences 2.7 Digital Image Analysis Algorithms 2.8 Cytopathology 2.9 Clinical Pathology 2.10 Veterinary Pathology 2.11 Multiplex High Medical Value Assays/ Decision Support Page 19 Page 20 Page 22 Page 32 Page 38 Page 43 Page 52 Page 54 Page 70 Page 93 Page 98 Page 104 Section 3 Business Justifications with a Positive Return on Investment 3.1 Workflow Considerations 3.2 Technology Considerations 3.3 Digital Pathology Informatics Standards 3.4 Reimbursement Page 105 Page 105 Page 115 Page 121 Page 124

6 Section 4 Getting Started and Beyond 4.1 Setting up Your Digital Pathology Lab 4.2 Validating Your Digital Pathology System 4.3 Training 4.4 Quality Assurance Page 127 Page 127 Page 134 Page 140 Page 147 Section 5 Regulatory Resources 5.1 Regulatory Resources Page 149 Page 150 Section 6 Tips for Including Whole Slide Images into Medical Courses and Publications 6.1 Medical Education 6.2 Online Digital Image Sharing 6.3 Mobile Pathology Apps 6.4 Publications Supplemented with Digital Images Page 153 Page 153 Page 188 Page 197 Page 209 Section 7 Insights from Current Users of Digital Pathology 7.1 Eric F. Glassy, MD, FCAP 7.2 Keith J. Kaplan, MD, FCAP 7.3 Andrew Evans, MD, PhD 7.4 Liron Pantanowitz, MD, FCAP 7.5 David C. Wilbur, MD, FCAP 7.6 Mohamed E. Salama, MD, FCAP 7.7 Thomas W. Bauer, MD, PhD, FCAP 7.8 Paul J. van Diest, MD, PhD 7.9 Scott W. Binder, MD, FCAP and W. Dean Wallace, MD, FCAP 7.10 Anil V. Parwani, MD, PhD, FCAP Page 213 Page 213 Page 216 Page 224 Page 230 Page 250 Page 255 Page 261 Page 267 Page 276 Page 280

7 Section 8 Insights from Digital Pathology Adopters Outside the United States 8.1 Canada 8.2 Asia 8.3 Europe 8.4 Emerging Markets Page 287 Page 287 Page 291 Page 296 Page 303 Section 9 Resources 9.1 CAP Center: Guidelines 9.2 Guidelines 9.3 CAP Proficiency Testing (PT) 9.4 CAP Laboratory Accreditation Program 9.5 CAP Education Programs 9.6 Digital Pathology Organizations 9.7 Industry Conferences 9.8 Archived Webinars 9.9 Platform and Vendor Overview Page 307 Page 307 Page 309 Page 312 Page 314 Page 315 Page 318 Page 320 Page 321 Page 323 Contributor Acknowledgement Page 327 Bibliography Page 329

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